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Quality Assurance

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Quality Assurance Services

  • GCP and GVP QMS (Quality Management System)
  • Good Clinical Practice Auditing
  • Good Clinical Laboratory Practice Auditing
  • Good Pharmacovigilance Auditing
  • Due Diligence
  • Mock Inspection
  • QMS (Quality Management System) Consultation
  • GCP, GVP, GCLP SOP (Standard Operating Procedures) Development

Pharmacovigilance Services

  • RMP (Risk Management Plan) Writing
  • Aggregated Report (DSUR/PSUR/PBRER) Writing
  • Localization of Global RMP/PBRER
  • Literature Search Service

Training

  • QA/Pharmacovigilance/CRO management/ Project management courses based on clients’ demand

Professional group with global auditor certificate

All auditors of C&R QA are members of RQA (Research Quality Association) in Europe, with a level I auditor certificate. In addition, lead auditors are registered to the U.S. SQA (Society of Quality Assurance) as registered quality assurance professionals or have an auditor certificate of ROA level II (or higher) in U.K.
Pharmacovigilance services experts have the U.S. certified safety officer certificate and participate in regular training for PV regulations prevailing in the U.S. and Europe. They are fully compliant with PV regulations at home and abroad.

Extensive experience in global QA services

C&R QA has extensive QA experience across a wide range of therapeutic areas for clinical research centers, pharmaceutical companies, and clinical research organizations in a number of Asian countries including China, Japan, Taiwan, and Korea as well as the U.S. With an experience of developing various standard operating procedures (SOPs) under mutual collaboration with the Ministry of Food and Drug Safety, C&R QA is currently engaged in crafting SOPs for clinical trials and PV services that meet client needs.

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